510(k) K810072

105MM ROLL FILM FLUOROGR. CAMERA, #105 by Scientex Corp. — Product Code IZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1981
Date Received
January 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, X-Ray, Fluorographic, Cine Or Spot
Device Class
Class II
Regulation Number
892.1620
Review Panel
RA
Submission Type